U.S. patent application number 14/789657 was filed with the patent office on 2016-06-02 for low profile standalone cervical interbody with screw locking clips and method of using same.
This patent application is currently assigned to ALLIANCE PARTNERS, LLC. The applicant listed for this patent is Alliance Partners, LLC. Invention is credited to Dwayne Lewis, Frank Morris, Kevin Richardson.
Application Number | 20160151166 14/789657 |
Document ID | / |
Family ID | 56078435 |
Filed Date | 2016-06-02 |
United States Patent
Application |
20160151166 |
Kind Code |
A1 |
Morris; Frank ; et
al. |
June 2, 2016 |
LOW PROFILE STANDALONE CERVICAL INTERBODY WITH SCREW LOCKING CLIPS
AND METHOD OF USING SAME
Abstract
A vertebrae stabilization device for stabilizing adjacent
vertebrae that is a cage having screw locking clips and method of
using same.
Inventors: |
Morris; Frank; (Austin,
TX) ; Lewis; Dwayne; (San Antonio, TX) ;
Richardson; Kevin; (San Antonio, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Alliance Partners, LLC |
San Antonio |
TX |
US |
|
|
Assignee: |
ALLIANCE PARTNERS, LLC
San Antonio
TX
|
Family ID: |
56078435 |
Appl. No.: |
14/789657 |
Filed: |
July 1, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62019662 |
Jul 1, 2014 |
|
|
|
Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61F 2/447 20130101;
A61F 2002/30481 20130101; A61F 2002/305 20130101; A61F 2002/30787
20130101; A61F 2002/30131 20130101; A61F 2002/30604 20130101; A61F
2/4455 20130101; A61F 2220/0016 20130101; A61F 2002/30904
20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A vertebrae stabilization device for stabilizing adjacent
vertebrae comprising: (a) a cage having a cage body with a top
surface, a bottom surface, a pair of side walls, a front wall and a
rear wall, and a window with a window perimeter, wherein the front
wall has a front face having a plurality of screw bores
therethrough; (b) a plurality of screws, wherein each of the screws
in the plurality of screws have a screw head and are dimensioned to
engage the corresponding screw bore in the plurality of screw
bores; and (c) a plurality of clips, wherein (i) each of the clips
in the plurality of clips comprises a resilient member and at least
one extension tab, and (ii) each of the screw bores in the
plurality of screw bores have walls dimensioned to receive and
locate the clip in the plurality of clips that corresponds to the
screw bore such that (A) the corresponding clip is operable to
engage the screw head of the corresponding screw in the plurality
of screws as the screw moves within the screw bore, and (B) the
resilient member of the clip is operable to move into an
interference position with respect to the screw head to prevent the
screw from backing out.
2. The vertebrae stabilization device of claim 1, wherein the tabs
are visible from the front face and are operable for indicating the
interference position.
3. The vertebrae stabilization device of claim 1, wherein the walls
of the screw bores (a) define a circumferential groove in the screw
bore for receipt of the resilient member thereinto, and (b) define
an axial groove for receipt of the extension tab.
4. The vertebrae stabilization device of claim 3, wherein the walls
defining an axial groove have an opening into the front face of the
front wall.
5. The vertebrae stabilization device of claim 1, wherein (a) the
front wall is a first color and the extension tabs are a second
color, and (b) the first color and the second color are contrasting
colors.
6. The vertebrae stabilization device of claim 1, wherein (a) the
body comprises a first portion comprising a first material, (b) the
body comprises a second portion comprises a second material, (c)
the first portion and the second portion resiliently engaging one
another.
7. The vertebrae stabilization device of claim 6, wherein the first
portion and the second portion are contrasting colors.
8. The vertebrae stabilization device of claim 6, wherein (a) the
first portion comprises a metal, and (b) the second portion
comprises a polymer.
9. The vertebrae stabilization device of claim 8, wherein (a) the
metal comprises titanium, and (b) the polymer comprises polyether
ether ketone.
10. The vertebrae stabilization device of claim 1, wherein each of
the screws in the plurality of screw has a threaded shank and the
screw head has a conical portion with a diameter greater than the
threaded shank.
11. The vertebrae stabilization device of claim 10, wherein the
resilient member of the clip is operable to move into the
interference position with respect to the screw head to prevent the
screw head from backing out.
12. A method of using a stabilizing device comprising the steps of:
(a) selecting a cage having a cage body with a top surface, a
bottom surface, a pair of side walls, a front wall and a rear wall,
and a window with a window perimeter, wherein (i) the front wall
has a front face having a plurality of screw bores therethrough,
(ii) the plurality of screw bores each have a clip comprising a
resilient member and at least one extension tab; (b) positioning
the cage adjacent to a first vertebrae body and a second vertebrae
body; (c) screwing a plurality of screws inserted through the screw
bores, wherein for each of the screws in the corresponding screw
bore (i) the screw is inserted into at least one of the first
vertebrae and the second vertebrae, (ii) the screw has a screw
head, (iii) the clip in the corresponding screw bore engages the
screw head of the screw as the screw moves through the
corresponding screw bore, and (iv) the resilient member of the clip
in the corresponding screw bore moves into an interference position
with respect to the screw head of the screw to prevent the screw
from backing out.
13. The method of claim 12, wherein the tabs are visible from the
front face and indicate the interference position.
14. The method of claim 12, wherein the walls of the screw bores
(a) define a circumferential groove in the screw bore for receipt
of the resilient member thereinto, and (b) define an axial groove
for receipt of the extension tab.
15. The method of claim 12, wherein (a) the front wall is a first
color and the extension tabs are a second color, and (b) the first
color and the second color are contrasting colors.
16. The method of claim 12, wherein (a) the body comprises a first
portion comprising a first material, (b) the body comprises a
second portion comprises a second material, (c) the first portion
and the second portion resiliently engaging one another.
16. The method of claim 16, wherein the first portion and the
second portion are contrasting colors.
18. The method of claim 16, wherein (a) the first portion comprises
a metal, and (b) the second portion comprises a polymer.
19. The method of claim 16, wherein each of the screws in the
plurality of screw has a threaded shank and the screw head has a
conical portion with a diameter greater than the threaded
shank.
20. The method of claim 19, wherein the resilient member of the
clip moves into the interference position with respect to the screw
head to prevent the screw from backing out.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application is a utility application claiming priority
to U.S. Provisional Application Ser. No. 62/019,662, filed on Jul.
1, 2014, entitled "LOW PROFILE STANDALONE CERVICAL INTERBODY WITH
SCREW LOCKING CLIPS," which provisional patent application is
commonly assigned to the Assignee of the present invention and is
hereby incorporated herein by reference in its entirety for all
purposes.
FIELD OF THE INVENTION
[0002] Screw anchored integrated vertebral standalone cage
assemblies having screw anti-backout clips.
BACKGROUND OF THE INVENTION
[0003] In an effort to stabilize adjacent vertebrae when disks must
be removed, a standalone interbody typically comprising a cage and
screws may be used. The term standalone means that the cage is used
without supplemental fixation, such as plates.
[0004] Screws are used which engage the cage of an interbody
assembly, which screws typically tap into the vertebrae bodies
above and below the cage for maintaining the cage positionally
within the bodies and for providing good compression of the two
vertebral bodies with the upper and lower surfaces of the cage.
[0005] To prevent screw backout, screw lockdown or anti-backout
mechanisms are known in the art. These mechanisms often include
some type of a member, independent of the cage, that engages both
the cage and a portion of the screw when the screw is at the
appropriate seated position with respect to the cage and the
vertebral bodies. An audible "click" is often used by the surgeon
to confirm the proper screw position. When the screws are properly
positioned and engaging a backout prevention member, the screw
heads and much of the screws may be within the cage body and thus
hard to visually observe. The relative positions of the screw and
the cage body often make difficult a visual confirmation the
backout/screw/cage is properly positioned.
SUMMARY OF THE INVENTION
[0006] A vertebrae stabilization device for stabilizing adjacent
vertebrae comprising a cage having a cage body with a top surface,
a bottom surface, a pair of side walls, a front wall and a rear
wall, a window and a window perimeter, the front wall having a
front face with multiple screw bores therethrough, a multiplicity
of screws, each having a threaded shank and a head having a conical
portion with a diameter greater than the shank. The screws are
dimensioned to engage the screw bores and the adjacent vertebrae. A
clip comprises a resilient member and at least one extension tab.
The screw bores have walls dimensioned to receive and locate the
clip such that the clip engages the screw head as the screw moves
within the screw bore. The resilient member of the clip moves into
an interference position with respect to the screw head to prevent
screw backout. The tabs of the resilient member are visible from
the front face of the cage and are indicative of said interference
position.
[0007] A vertebrae stabilization device is provided wherein walls
are dimensioned to engage a clip include walls defining a
circumferential groove in a screw bore for receipt of a resilient
member thereinto. Walls defining an axial groove are provided for
receipt of the extension tab. The walls defining an axial groove
open into the front face of the front wall. The front wall is a
first color and the extension tabs are a second, contrasting color.
The cage body includes a first portion comprising a first material
and a second portion comprises a second material, the two portions
resiliently engaging one another.
[0008] A purpose of the resilient member is to provide visual
confirmation that the resilient member is in an interference
position with regard to the top of the screw. In an interference
position, the resilient member which also engages the cage will
prevent the screw from backing out.
[0009] In general, in one aspect, the invention features a
vertebrae stabilization device for stabilizing adjacent vertebrae.
The vertebrae stabilization device includes a cage having a cage
body with a top surface, a bottom surface, a pair of side walls, a
front wall and a rear wall, and a window with a window perimeter.
The front wall has a front face having a plurality of screw bores
therethrough. The vertebrae stabilization device further includes a
plurality of screws. Each of the screws in the plurality of screws
have a screw head and are dimensioned to engage the corresponding
screw bore in the plurality of screw bores. The vertebrae
stabilization device further includes a plurality of clips. Each of
the clips in the plurality of clips includes a resilient member and
at least one extension tab. Each of the screw bores in the
plurality of screw bores have walls dimensioned to receive and
locate the clip in the plurality of clips that corresponds to the
screw bore such that (A) the corresponding clip is operable to
engage the screw head of the corresponding screw in the plurality
of screws as the screw moves within the screw bore, and (B) the
resilient member of the clip is operable to move into an
interference position with respect to the screw head to prevent the
screw from backing out.
[0010] Implementations of the inventions can include one or more of
the following features:
[0011] The tabs can be visible from the front face and can be
operable for indicating the interference position.
[0012] The walls of the screw bores can define a circumferential
groove in the screw bore for receipt of the resilient member
thereinto. The walls of the screw bore can define an axial groove
for receipt of the extension tab.
[0013] The walls defining an axial groove can have an opening into
the front face of the front wall.
[0014] The front wall can be a first color and the extension tabs
can be a second color. The first color and the second color can be
contrasting colors.
[0015] The body can include a first portion that includes a first
material. The body can include a second portion that includes a
second material. The first portion and the second portion can
resiliently engage one another.
[0016] The first portion and the second portion can be contrasting
colors.
[0017] The first portion can include a metal. The second portion
can include a polymer.
[0018] The metal can include titanium. The polymer can include
polyether ether ketone.
[0019] Each of the screws in the plurality of screw can have a
threaded shank and the screw head can have a conical portion with a
diameter greater than the threaded shank.
[0020] The resilient member of the clip can be operable to move
into the interference position with respect to the screw head to
prevent the screw head from backing out.
[0021] In general, in another aspect, the invention features a
method of using a stabilizing device. The method includes selecting
a cage having a cage body with a top surface, a bottom surface, a
pair of side walls, a front wall and a rear wall, and a window with
a window perimeter. The front wall has a front face having a
plurality of screw bores therethrough. The plurality of screw bores
each have a clip including a resilient member and at least one
extension tab. The method further includes positioning the cage
adjacent to a first vertebrae body and a second vertebrae body. The
method further includes screwing a plurality of screws inserted
through the screw bores. For each of the screws in the
corresponding screw bore: (i) the screw is inserted into at least
one of the first vertebrae and the second vertebrae, (ii) the screw
has a screw head, (iii) the clip in the corresponding screw bore
engages the screw head of the screw as the screw moves through the
corresponding screw bore, and (iv) the resilient member of the clip
in the corresponding screw bore moves into an interference position
with respect to the screw head of the screw to prevent the screw
from backing out.
[0022] Implementations of the inventions can include one or more of
the following features:
[0023] The tabs can be visible from the front face and can indicate
the interference position.
[0024] The walls of the screw bores can define a circumferential
groove in the screw bore for receipt of the resilient member
thereinto. The walls of the screw bores can define an axial groove
for receipt of the extension tab.
[0025] The front wall can be a first color and the extension tabs
can be a second color. The first color and the second color can be
contrasting colors.
[0026] The body can include a first portion that includes a first
material. The body can include a second portion that includes a
second material. The first portion and the second portion can
resiliently engage one another.
[0027] The first portion and the second portion can be contrasting
colors.
[0028] The first portion can include a metal. The second portion
can include a polymer.
[0029] Each of the screws in the plurality of screw can have a
threaded shank and the screw head can have a conical portion with a
diameter greater than the threaded shank.
[0030] The resilient member of the clip can be operable to move
into the interference position with respect to the screw head to
prevent the screw head from backing out.
BRIEF DESCRIPTION DRAWINGS THE DRAWINGS
[0031] FIG. 1A illustrates an exploded perspective view of
Applicant's interbody assembly.
[0032] FIG. 1B illustrates a side elevational view of the cage.
[0033] FIGS. 1C-1D are perspective views of the cage of the
interbody assembly.
[0034] FIG. 1E is a perspective view showing the cage, screws, and
insert that comprise the interbody assembly.
[0035] FIGS. 2A-2B illustrate cross-sectional views of the position
of the screw with respect to the clip and the cage as the screw
advances through the screw bore.
[0036] FIGS. 2C-2D are partial elevational views of the tab
extensions with respect to the tab cutouts in their relative
positions just prior to clip lock (FIG. 2C) and at clip lock (FIG.
2D).
[0037] FIGS. 3A-3B are perspective and side elevational views of
the clip of Applicant's interbody assembly.
[0038] FIG. 4A illustrates a screw in cross-sectional view.
[0039] FIG. 4B illustrates an alternate preferred embodiment of a
screw for use with Applicant's assembly.
[0040] FIG. 5 is an exploded view of one embodiment of the cage of
Applicant's interbody assembly.
REFERENCE NUMERALS
[0041] 10 Interbody assembly
[0042] 11 Cage
[0043] 12/14/16 Clips
[0044] 18 Screws
[0045] 20 First, anterior portion
[0046] 22 Second, posterior portion
[0047] 24/26 Engagement members
[0048] 24a Notched resilient arm
[0049] 26a Recess/slot
[0050] 28 Top surface
[0051] 30 Bottom surface
[0052] 32/34 Left/right side walls
[0053] 36 Front wall having a front face
[0054] 36a Front face
[0055] 40 Rearwall
[0056] 42 Window
[0057] 42a Window perimeter
[0058] 44/46/48 Walls of screw guide bores (left to right)
[0059] 54/56/58 Clip cutouts
[0060] 54a/56a/58a Tab cutouts
[0061] 54b/56b/58b Clip cutouts
[0062] 60 Resilient connector arm
[0063] 62/64 Tab extensions
[0064] 70 Head
[0065] 72 Shank
[0066] 74 Threads
[0067] 76 Self-cutting tip
[0068] 78 Conical portion
[0069] 79 Bottom of head
[0070] 80 Top surface of head
[0071] 82 Tool engaging extension/recess
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0072] FIG. 1A illustrates the three main components of the
interbody assembly 10 of the present invention. Cage 11 functions,
in part, to maintain separation between a vertebra above and a
vertebra below the interbody assembly. Screws 18 (a total of three
as shown in the embodiment illustrated in FIG. 1A) provide fixation
or location and stability of the cage to the vertebrae above and
the vertebrae below the cage. Resilient clips 12/14/16, in the
embodiment illustrated in FIG. 1A, engage both the cage 11 and the
top of the screws 18 when the screw 18 is fully inserted into the
cage 11 in a manner that prevents the screw 18 from, in time,
backing out. Cages, clips, and screws generally are known in the
art.
[0073] As seen in FIGS. 1A-5, the cage 11 of the present invention,
in one embodiment, may include a first, anterior portion 20 and a
second posterior portion 22. Engagement members 24/26 provide for
engagement, such as tool-less resilient engagement, of a notched
resilient arm 26a with a recess/slot 24a, which engagement couples
the first portion 20 to the second portion 22 in a locking, rigid
manner. In one embodiment, a first portion 20 is made of titanium
or other suitable metal and a second portion 22 is made of PEEK
(polyether ether ketone) or other suitable non-metallic material. A
function of two parts made of dissimilar materials to form cage 11
is for support and color contrast.
[0074] As oriented in FIGS. 1A-1B, cage 11 is shown as having a top
surface 28 and a bottom surface 30, the plane of the top surface 28
and bottom surface 30 angled to reflect the lordotic relationship,
to match normal lordotic curvature, as is known in the art. Cage 11
is also seen to have left and right side walls 32/34. A front wall
36 engages the two side walls 32/34 and may have a front face 36a
thereon. A rear wall 40 connects the rear portions of the two side
walls 32/34. The side walls 32/34, front wall 36, and rear wall 40
forming a generally rectangular structure with at least one window
42 therein (shown in FIG. 1C). Window 42 is defined by a window
perimeter 42a and may receive a graft material or otherwise allow
bone from the upper and lower vertebrae bodies to fuse through the
cage 11.
[0075] Cage 11 may include multiple walls 44/46/48 defining
multiple screw guide bores (see FIG. 1D, left to right). Within
each screw bore is a clip cutout 54/56/58. Clip cutouts are shaped
to receive resilient clips 12/14/16 thereinto as seen in FIG.
1A.
[0076] Clip cutouts 54/56/58 may include circumferentially
(typically about 180.degree. around the screw bore) connector arm
cutouts 54a/56a/58a as well as tab cutouts 54b/56b/58b. Clips
12/14/16 are resilient, and clips 12/14/16 may be squeezed slightly
together at the tabs and inserted into the bore (without the screws
in the bore), released adjacent each of the clip cutouts and they
will pop out to engage the tab cutouts and connector arm cutouts as
seen, for example, as shown in FIG. 1D. At least a portion of the
bottom walls of the tabs extend into the screw bores when no screw
is in bore.
[0077] Clips 12/14/16 are typically made out of a resilient,
metallic material, such as titanium, in a color highly contrasting
to the color of the front wall. For example, in one embodiment, the
first portion 20, including front wall 36 and front face 36a, are
comprised of a gold anodized titanium and the clips, including tab
extensions 62/64, are green. Because of the function of visual
confirmation of clip seating (interference position), it is
believed the color contrast is advantageous. It is also noted that
neither the color of the cage nor the clip are colors typically
found in or about the operation site, that is, the colors of bone
or bodily fluids.
[0078] As seen in FIGS. 1A, 1E, 2A-2B, and 4A, screws 18 are
generally comprised of a head 70 having a top surface 80, a
threaded shank 72 having threads 74 thereon. The threads 74, in one
embodiment, have a bone-cutting tip 76 through the removed thereof.
A tool engaging extension (FIG. 4A) or recess (FIG. 4B) 82 may
extend from or recess into the top surface of the head 70.
[0079] Head 70 is seen to include a bottom 79 and conical portion
78 having outwardly tapered (from bottom to top) sidewalls thereon.
The tool engaging portion is for driving the screw through the
screw guide bores and then into the bone. The screw guide bores
have an axis that will guide the screws such that the outer two are
directed up or down and the center is directed the other way.
[0080] When the screws 18 are inserted fully into the screw bores,
the conical portion is flush against a conical portion of the
removed ends of the screw bores and such that the center points of
the screw heads are aligned on a line that, in one embodiment may
approximate the midline of the front wall.
[0081] Referring to FIGS. 2A-2B, it is seen that tab cutouts
54b/56b/58b are generally configured with the same perimeter shape
(but slightly larger) when viewed in the views of FIGS. 2C-2D of
the tabs which they are received thereinto. Moreover, as
illustrated in FIG. 2C, the tabs are pushed flush against the wall
of the cutouts, and the outer face of the tabs conforms to the
inner face of the cutouts. As the screw 18 advances into the screw
bore, the threads of the shank cut into the bone, the removed
(outer) end of the tabs will first encounter the lower end 79 of
conical portion 78 of the screw head and be pushed outward so they
are generally flush as illustrated in FIG. 2C. FIG. 2A shows the
connector arm 60 just at its initial encounter of the lower end 70
of the screw.
[0082] At this point, the tabs are in contact with the upper area
of conical portion 78. Continued advancement brings the resilient
connector arms to the position shown in FIG. 2C, in which the
inserts are fully seated into the cutouts and also where the
connector arms 60 are fully seated in connector arm cutouts
54a/56a/58a. The instant the screw advances past that position, the
resilient arms will pop or snap into a position on top of head 80
(see FIG. 1E center screw). The removed end of the tab extensions
62/64 will move from the position shown in FIG. 2C to the position
shown in FIG. 2D, where it becomes spaced apart providing a visual
indication to the surgeon that the clips (anti-backout) are in an
interference position.
[0083] A number of embodiments of the invention have been
described. Nevertheless, it will be understood that various
modifications may be made without departing from the spirit and
scope of the invention. Accordingly, other embodiments are within
the scope of the following claims.
[0084] While embodiments of the invention have been shown and
described, modifications thereof can be made by one skilled in the
art without departing from the spirit and teachings of the
invention. The embodiments described and the examples provided
herein are exemplary only, and are not intended to be limiting.
Many variations and modifications of the invention disclosed herein
are possible and are within the scope of the invention.
Accordingly, other embodiments are within the scope of the
following claims. The scope of protection is not limited by the
description set out above, but is only limited by the claims which
follow, that scope including all equivalents of the subject matter
of the claims.
* * * * *